Cold Medicines For Under Age 6 Should Be Banned, Says FDA Panel

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Main Category: Pediatrics / Children's Health
Also Included In: Respiratory / Asthma;  Regulatory Affairs / Drug Approvals;  Ear, Nose and Throat
Article Date: 20 Oct 2007 - 0:00 PDT


OTC cough and cold drugs for children less than six years of age should be banned, said a US Food and Drug Administration (FDA) panel. They expressed concern about safety and lack of clinically proven evidence regarding their effectiveness. In fact, the Panel said there is not evidence available to prove that these OTC (over-the-counter) drugs for colds have any benefits for children under 12.

The panel added that there is a risk of dangerous, sometimes even fatal overdoses, as well as other adverse events for small children. They proposed that the FDA should make pharmaceutical companies carry out studies on OTC medicines for kids over the next three years.

Last week pharmaceutical companies withdrew over a dozen medications for colds designed for children under two after health care professionals had voiced concern over safety and the risk that some parents may overdose their kids accidentally.

Members of the panel said cold drugs aimed at small children should not have such phrases as "doctor recommended" written on them. They believe there should be a warning on the labels advising people not to use them on kids under the age of six.

The Panel's recommendation is only that, the FDA is under no obligation to follow it. However, history has shown that the FDA usually goes along with what the Panel advises.

The recommendation applies to drugs which contain one or more of the following ingredients:

-- decongestants (drugs that reduce symptoms of nasal congestion - blocked nose)
-- antihistamines (medicines used to prevent the symptoms of an allergic reaction)
-- antitussives (used to suppress coughs, especially dry coughs)

The recommendation does NOT apply to expectorants - expectorants are used to thin and bring up mucus from the lungs when you cough.

The Panel's recommendation will probably lead to a transformation on how medications are used, marketed and labeled. How soon this may happen is another question. Restricting the use of a drug for children under six does not necessarily mean it will be taken off the market. More likely its labeling will include a warning that it should not be used for small children. For the FDA to get the new rules into place, and then implement them could be many years away. However, the FDA may try to encourage the industry to make the changes before the new regulations are set, which may speed things up.

The panel had to vote on three main motions:

1. These medicines should not be used for children under 2 - The panel agreed.
2. These medicines should not be used for children under 6 - The panel agreed.
3. These medicines should not be used for children aged 6-11 - The vote failed

The drug industry says these medicines do work. The Panel says evidence that they work in young children is lacking. Some of these drugs have never been tested on children, such as Pediacare (Johnson & Johnson) and Dimetapp (Wyeth). This lack of testing of cough and cold drugs aimed at children was mentioned by the FDA panel over three decades ago.

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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